As of October 31, 2011, all site staff who are active reporters in DAERS have the ability to create EAE Reports on all current and future protocols at the site. New staff must be added. Submitters must still be designated for all protocols.

The protocol uses the old DAIDS SAE manual. (EAE reports for these protocols cannot be submitted through DAERS; they must be submitted by email/fax. If you do not have a copy of the old SAE form, please request a copy from the DAIDS RSC).

The protocol does not require reporting through DAIDS because the protocol is not sponsored by DAIDS.

The protocol is a substudy and EAEs are reported through a main study.

If the protocol that you need is not showing up in your drop-down list for a reason that is not listed above, then contact NIAID CRMS Support (CRMSsupport@niaid.nih.gov). If you need to report an EAE right away, please be aware that all CRS Leaders and Coordinators have access to report EAEs on all protocols at their site. In emergency circumstances, you can report via the paper EAE form found on the RSC web site.

The DMCs provide the accrual data for the PIDs to NIAID CRMS. This data is uploaded and quality checked by NIAID CRMS. This might result in a lag and thus the PID may not be displayed in DAERS. It is also possible that the DMC has not submitted updated PID data to NIAID CRMS at the time you are entering the EAE. In both cases, you may manually enter the PID. Additionally, the PID in DAERS does not include a check digit. You may miss the PID in the list of values if you are looking for a check digit.

HIV status date is the date the last test for HIV was conducted on the participant.

If the actual HIV Status date is not known at the time of reporting, the estimated HIV status date should be entered and the reporter should indicate the date is estimated by checking the estimated flag.

The HIV Status fields are optional. For studies that require participants to be HIV Infected, you may choose to skip this section.

The HIV Status fields are helpful for studies that require participants to be HIV Uninfected, such as in Prevention and Vaccine trials, where HIV Status tests are routinely required. This information is helpful to track over the course of the study and to give the RSC and the DAIDS Medical Officers a complete picture of the participant’s EAE.

If there were any Concomitant medications that may have contributed to the primary adverse event, the details should be entered one by one in the Concomitant medications section. Any additional Concomitant medications being taken at the onset of the primary adverse event should be faxed, e-mailed, or attached to the report using the Additional Information screen.Note: The RSC will create an update report in DAERS to enter additional information received via e-mail or fax.

You may attach/upload additional information for the EAE in the Additional Information section. You must select the ‘Uploaded in DAERS’ checkbox in the applicable section if you are attaching additional information for Primary Adverse Event, Concomitant Medications, Laboratory Tests or Diagnostic Tests.

If you are reporting an initial event, create a new EAE in DAERS. Go directly to the Study Vaccine page if you have entered the information prior to this page. Fields will no longer be grayed out once you select your study vaccine when entering information for the first time in an Initial EAE.

If you are updating an event which requires adding the dates of administration, start by searching for the event, select Update, and save the Reporter Information screen to create the EAE update. Once you create the update, go to the Study Vaccine page. For an update, the bottom of the screen will list the vaccine(s) that you have previously entered, in blue. Once you click on the vaccine, you will be able to edit the vaccine information.

Entering dates of administration: First select a date on the calendar or type directly into the Dates of Administration field in the DD/MM/YYYY format. Once you have selected or typed the first date of administration, click the blue (+) icon to the right of the date. This adds the date to the system. *Important note:* Even if you are entering only one vaccination date, you still need to click the blue (+) icon in order for the date to save in the system. You will notice that action adds the dates below the Dates of administration field.

In order to enter additional dates, repeat the same steps as above. Select a date on the calendar or type it directly into the field, and then click on the blue (+) icon to add the date to the system. You will then see both dates listed below the Dates of Administration field, indicating both dates have been entered. If you enter a date incorrectly, there are blue (-) icons next to each date, which you can click on to delete the date.

Once you have entered all dates of vaccination, click the Save button at the bottom of the page and wait for the green “Successfully saved…” message to ensure that the information has been properly captured in the system. To enter another vaccine, click New and repeat above steps for entering the date(s) of administration.

For an Initial: continue to enter all other applicable information on the other screens, and go through Completion Check once you have entered all pertinent information. The Submitter can then submit the event.

For an Update: If this is the only information you are updating, go through Completion Check and have the Submitter at your site submit the update. If there is additional information to be added, complete all other updated information and then go through Completion Check and have the Submitter at your site submit the update.